The purpose of this study is to evaluate the analgesic effectiveness of direct current stimulation (tsDCS) in the treatment of pelvic pain by comparing three groups: * Trans-spinal tsDCS stimulation, * Ganglionic tsDCS stimulation, * Placebo (sham) tsDCS stimulation.
Conduct of study: Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via Redcap. Only this physician will have the knowledge of the group allocated to the patient. Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week. Treatment sessions: after the baseline, sessions of neurostimulation will begin for 5 weeks. After the end of neurostimulation sessions, patients will be followed for 2 weeks. Throughout their participation in the study, patients will plot on a diary form their daily VNS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
Direct current stimulation (tsDCS) protocol consist of one daily session for five consecutive days during the first week, followed by one session per week until week 5, after which the treatment period ends and post-treatment follow-up begins.
Clinical Neurophysiology Unit, Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), Créteil, France
Créteil, France
Pain Management Center, Grenoble Alpes University Hospital (CHU Grenoble Alpes)
Grenoble, France
Evolution of Pain
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Pain Scale (VNPS): The patient will raise his pain level on a follow-up diary each day. The VNPS average will be calculated for each week. The VNS is a 10-point scale, ranging from 0 (worse) to 10 (better).
Time frame: Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Rate of Responding Patients
Patients will be classified as "responders" if they show a reduction in NVPS (Numeric Visual Pain Scale) scores equal to or greater than 30%
Time frame: week 7 compared with baseline
Evaluation of the analgesic effect maintenance
Comparison between groups of the daily Numeric Visual Pain Scale (NVPS) values, averaged over 7 days
Time frame: Between Week 5 (end of treatment) and Weeks 6 to 7 (post-treatment follow-up).
Assessment of Overall Patient Improvement.
Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline
Quality of Life Improvement.
Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire. SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.
Time frame: Day 50 from the beginning of tsDCS stimulation treatment compared to baseline
Evolution of Anxiety and Depressive Traits.
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Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline
Evolution of Symptomatological Profiles of Neuropathic Pain.
Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline.
Autonomous System Assessement.
Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.
Time frame: Day 50 from the beginning of tsDCS treatment compared to baseline.
Evolution of the use of analgesic treatments.
Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.
Time frame: From baseline to day 50.